Preparation technique of mezlocillin sodium freeze-dried powder

A technology for preparing mezlocillin sodium, which is applied in the direction of freeze-drying transportation, powder transportation, antibacterial drugs, etc., can solve the problems of high processing cost, low yield, cumbersome steps, etc., and achieve low processing cost and high yield , the effect of simple steps

Inactive Publication Date: 2011-04-13
JIANGSU HI STONE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the processing technology of mezlocillin sodium in the prior art has cumbersome steps, low yield and high processing cost, and is not suitable for mass production

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Take 20.0kg of mezlocillin and 100L of distilled water in a reaction tank in a 10,000-level clean area, stir to fully suspend, then add saturated sodium bicarbonate solution to adjust the pH to 4.5, continue stirring for 30 minutes, and the mezlocillin is completely Dissolve, add 0.3kg of activated carbon (equivalent to 0.3% liquid) into it after the dissolution is complete, stir and decolorize at room temperature for 30 minutes, first filter with filter paper, and pass the crude filtrate into a 100-level clean area after filtering, filter with 0.22um Membrane fine filtration, put the fine filtrate into a treated freeze-drying tray, use the freeze-drying method to sublimate the water, collect the material after freeze-drying, grind it through a pulverizer, and pass through a 60-mesh sieve to obtain off-white merlot 20.2kg of cillin sodium sterile powder, yield: 96.0%.

Embodiment 2

[0018] Take 20.0kg of mezlocillin and 100L of distilled water in a reaction tank in a 10,000-level clean area, stir to fully suspend, then add saturated sodium bicarbonate solution to adjust the pH to 6, continue stirring for 30 minutes, and the mezlocillin is completely Dissolve, add 0.3kg of activated carbon (equivalent to 0.3% liquid) into it after the dissolution is complete, stir and decolorize at room temperature for 30 minutes, first filter with filter paper, and pass the crude filtrate into a 100-level clean area after filtering, filter with 0.22um Membrane fine filtration, put the fine filtrate into a treated freeze-drying tray, use the freeze-drying method to sublimate the water, collect the material after freeze-drying, grind it through a pulverizer, and pass through a 60-mesh sieve to obtain off-white merlot 20.5kg of cillin sodium sterile powder, yield: 96.5%.

Embodiment 3

[0020] Take 20.0kg of mezlocillin and 100L of distilled water in a reaction tank in a 10,000-level clean area, stir to fully suspend, then add saturated sodium bicarbonate solution to adjust the pH to 7.5, continue stirring for 30 minutes, and the mezlocillin is completely Dissolve, add 0.3kg of activated carbon (equivalent to 0.3% liquid) into it after the dissolution is complete, stir and decolorize at room temperature for 30 minutes. Membrane fine filtration, put the fine filtrate into a treated freeze-drying tray, use the freeze-drying method to sublimate the water, collect the material after freeze-drying, grind it through a pulverizer, and pass through a 60-mesh sieve to obtain off-white merlot 20.4kg of cillin sodium sterile powder, yield: 98.0%.

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PUM

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Abstract

The invention relates to a preparation technique of mezlocillin sodium freeze-dried powder, which comprises the following steps of: (1) mixing and stirring mezlocillin and distilled water; (2) adding saturated sodium bicarbonate solution until the pH value of the reaction liquid reaches 4.5-7.5, and continuing stirring; (3) adding activated carbon, which accounts for 0.3% of the reaction liquid by volume, to the reaction liquid, and stirring to decoloring the reaction liquid; (4) carrying out rough filtration by using filter paper, and carrying out fine filtration on the rough filtration liquid by using a 0.22 mum filter membrane; (5) sublimating water in the fine filtration liquid by freeze-drying; and (6) collecting the material, pulverizing and screening to obtain the mezlocillin sodium aseptic powder. The preparation technique has the advantages of simple procedure, high yield and low processing cost, and is suitable for mass production.

Description

technical field [0001] The invention relates to a preparation process of mezlocillin sodium freeze-dried powder, belonging to the technical field of medicine. Background technique [0002] Mezlocillin sodium, the English name is Mezlocillin Baypen, its chemical name is (2S, 5R, 6R)-3,3-dimethyl-6-[(R)-2[3-(methylsulfonyl)-2 -Oxo-1-imidazolidinecarboxamido]-2-phenylacetamido]-7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic acid sodium salt. It is mainly used for infections of the respiratory system, urinary system, digestive system, gynecology and reproductive organs caused by sensitive strains of Gram-negative bacilli such as Escherichia coli, Enterobacter, and Proteus, such as sepsis, suppurative meningitis, and peritonitis , Osteomyelitis, skin and soft tissue infections, and eye, ear, nose, and throat infections. [0003] At present, the processing technology of mezlocillin sodium in the prior art has cumbersome steps, low yield and high processing cost, and is no...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/431A61P31/04
Inventor 王多平
Owner JIANGSU HI STONE PHARMA
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